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FDA 510(k)

SURE COUNT 5 & 10 SPONGE COUNTER

K-Number: K853454 · 1985-09-05

ApplicantKleen Test Products
Decision Date1985-09-05
Product Code
DecisionSubstantially Equivalent

Device Summary

SURE COUNT 5 & 10 SPONGE COUNTER is the device name listed in this FDA 510(k) record. The listed applicant is Kleen Test Products. It received FDA 510(k) clearance on 1985-09-05 under 510(k) number K853454. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE COUNT 5 & 10 SPONGE COUNTER?

SURE COUNT 5 & 10 SPONGE COUNTER is a medical device that received FDA 510(k) clearance on 1985-09-05. The listed applicant is Kleen Test Products. The 510(k) number is K853454.

When did SURE COUNT 5 & 10 SPONGE COUNTER receive FDA 510(k) clearance?

SURE COUNT 5 & 10 SPONGE COUNTER received FDA 510(k) clearance on 1985-09-05, under 510(k) number K853454.

Who is the listed applicant for SURE COUNT 5 & 10 SPONGE COUNTER?

The FDA 510(k) record lists Kleen Test Products as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Kleen Test Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K890039KLEEN TEST BASIN SETK890539SURE COUNT LIGHT HANDLE COVERK890098KLEEN TEST O.R. KITK853622SURE COUNT 30 COUNT FOAM & MAGNETIC 92-3030K853315CAUTERY TIP CLEANING PADK852258SURE-COUNT 30 COUNT MAGNETIC NEEDLE COUNTER

View all 17 devices →

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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